From Buy
Wednesday, March 2, 2022
Bright Health Group 2021 Results, 2022 Outlook, Call
"Bright Health Group achieved substantial growth in 2021, delivering $4 billion in Revenue, and reaching a significant scale milestone of serving over 1 million health plan lives for the start of 2022. While progressing on important foundational capabilities, this level of growth created challenges during the year which resulted in worse than expected performance," said Mike Mikan, President and CEO of Bright Health Group. "Despite a challenging 2021, we have conviction in our strategy to continue driving alignment and integration of care delivery and financing at the local level. None of this is possible without an incredible team who deeply care about making healthcare right for consumers and we are focused on driving results off our scaled platform in 2022 and beyond."
Financial Outlook
For full year 2022, Bright Health Group is providing the following guidance and commentary:
Bright Health Group’s total Revenue is expected to be $6.8 billion to $7.1 billion with an expected enterprise Medical Cost Ratio between 90% and 94%.
On a segment basis, Bright HealthCare end-of-year membership is expected to be approximately 1,000,000, while NeueHealth Revenue is expected to be approximately $2.3 billion.
Intercompany Revenue elimination, comprised of payments from Bright HealthCare to NeueHealth for managing patient care and for network services, is expected to be approximately $1.2 to $1.4 billion.
Adjusted EBITDA for 2022 is expected to be a loss of between $500.0 and $800.0 million†.
Earnings Conference Call
As previously announced, Bright Health Group will discuss the Company’s results, strategy, and outlook on a conference call with investors at 8:00 a.m. Eastern Time today. Bright Health Group will host a live webcast of this conference call which can be accessed from the Investor Relations page of the company’s website (investors.brighthealthgroup.com). Following the call, a webcast replay will be available on the same site. calls and webcasts.
https://finance.yahoo.com/news/bright-health-group-reports-fourth-114500724.html
ChemoCentryx: 2021 Financial Results and Recent Highlights
“In 2021 we achieved our long-standing goal of becoming an integrated US biopharmaceutical enterprise: one that discovers, develops and now markets innovative medicines of our own devising,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “TAVNEOS® was approved and launched in the United States in October and we are seeing growing momentum in the number of patient start forms, patients on drug and the numbers of unique and repeat prescribers. In this initial phase of the launch, we are focused on educating physicians and patients about TAVNEOS and using appropriate support programs to minimize barriers to access for eligible patients. Moreover, with the approval in ANCA-associated vasculitis, the potential for TAVNEOS may only have just begun. We now also intend to launch clinical development in lupus nephritis this year, and to meet with the FDA to discuss the path forward in both severe hidradenitis suppurativa and C3 glomerulopathy, following our Phase II clinical trials in those indications.
Our pipeline continues to develop beyond TAVNEOS as well. Phase I clinical development of our orally-administered PD-L1/PD-1 checkpoint inhibitor, CCX559, is proceeding according to plan, where we expect to present initial data from the ongoing CCX559 dose escalation study this year. In short, 2021 was a watershed year in the evolution of ChemoCentryx, and we expect 2022 to see further progress in our quest to help patients to enjoy better lives.”
Conference Call and Webcast
The Company will host a conference call and webcast today, March 1, 2022, at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 3136966. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.ChemoCentryx.com. The archived webcast will remain available on the Company's website for fourteen (14) days following the call.
https://finance.yahoo.com/news/chemocentryx-reports-fourth-quarter-full-210500040.html
Karyopharm: FDA says current data unlikely to support application approval
During a productive meeting with the FDA, the Company received feedback that the current SIENDO study top-line results are unlikely to support an sNDA approval. Karyopharm and the FDA participants had differing views on the study significance and overall clinical benefit for the whole population and discussed that further exploration of patients with advanced or recurrent endometrial cancer with p53 wild-type is warranted. The Company will continue to collect and analyze the SIENDO study data and work with the FDA to explore all regulatory pathways for patients with p53 wild-type. In addition, considering the FDA's feedback, the Company intends to initiate a new placebo-controlled, randomized clinical study of selinexor in patients with p53 wild-type endometrial cancer and believes top-line data will be available in the first half of 2024. Karyopharm plans to rapidly initiate this study of selinexor in patients with p53 wild-type this year, working with the FDA as well as established networks and partners, including the European Network of Gynaecological Oncological Trial groups (ENGOT) and the Gynecologic Oncology Group Foundation, Inc. (GOG-F).
https://finance.yahoo.com/news/karyopharm-provides-u-regulatory-selinexor-210500167.html
Organogenesis 2021 results, 2022 guidance, call
Fiscal Year 2021 Results:
The following table represents net revenue by product grouping for the year ended December 31, 2021 and December 31, 2020, respectively:
Year Ended December 31, | Change | |||||||||||||||
2021 | 2020 | $ | % | |||||||||||||
(in thousands, except for percentages) | ||||||||||||||||
Advanced Wound Care | $ | 430,839 | $ | 294,624 | $ | 136,215 | 46 | % | ||||||||
Surgical & Sports Medicine | 37,220 | 43,674 | (6,454 | ) | (15 | %) | ||||||||||
Net revenue | $ | 468,059 | $ | 338,298 | $ | 129,761 | 38 | % | ||||||||
Net revenue for the year ended December 31, 2021 was $468.1 million, compared to $338.3 million for the year ended December 31, 2020, an increase of $129.8 million, or 38%. The increase in net revenue was driven by a $136.2 million increase, or 46%, in net revenue of Advanced Wound Care products, partially offset by a $6.5 million decrease, or 15%, in net revenue of Surgical & Sports Medicine products compared to the prior year.
Net income for the year ended December 30, 2021 was $94.9 million, or $0.71 per share, compared to a net income of $17.2 million, or $0.15 per share, for the year ended December 31, 2020.
Adjusted net income of $101.3 million for the year ended December 31, 2021, compared to adjusted net income of $20.0 million for the year ended December 31, 2020.
Adjusted EBITDA of $89.1 million for the year ended December 31, 2021, compared to Adjusted EBITDA of $38.8 million for the year ended December 31, 2020.
Fiscal Year 2022 Guidance:
For the year ending December 31, 2022, the Company expects:
Net revenue of between $485 million and $515 million, representing an increase of approximately 4% to 10% year-over-year, and 6% to 13% on an adjusted basis3, as compared to net revenue of $468.1 million for the year ended December 31, 2021.
The 2022 net revenue guidance range assumes:
Net revenue from Advanced Wound Care products of between $455 million and $481 million, representing an increase of approximately 6% to 12% year-over-year as compared to net revenue of $430.8 million for the year ended December 31, 2021.
Net revenue from Surgical & Sports Medicine products of between $30 million and $34 million, representing a decrease of approximately 9% to 19% year-over-year as compared to net revenue of $37.2 million for the year ended December 31, 2021.
Net revenue from the sale of PuraPly products of between $207 million and $217 million, representing an increase of approximately 4% to 9% year-over-year, as compared to net revenue of $198.5 million for the year ended December 31, 2021.
Net income of between $56.5 million and $71.5 million and adjusted net income of between $60.2 million and $75.2 million.
EBITDA of between $73.5 million and $88.9 million and Adjusted EBITDA of between $79.9 million and $95.3 million.
Fourth Quarter 2021 Earnings Conference Call:
Financial results for the fourth fiscal quarter of 2021 will be reported after the market closes on Tuesday, March 1.
Management will host a conference call at 5:00 p.m. Eastern Time on March 1 to discuss the results of the quarter and the fiscal year, and provide a corporate update with a question and answer session. Those who would like to participate may dial 866-795-3142 (409-937-8908 for international callers) and provide access code 5998131. A live webcast of the call will also be provided on the investor relations section of the Company's website at investors.organogenesis.com
For those unable to participate, a replay of the call will be available for two weeks at 855-859-2056 (404-537-3406 for international callers); access code 5998131. The webcast will be archived at investors.organogenesis.com.
https://finance.yahoo.com/news/organogenesis-holdings-inc-reports-fourth-210500157.html
Novartis backs Epsilogen's bid to turn 'Cinderella antibody' into new class of cancer drug
Novartis has thrown its weight behind a “Cinderella antibody,” leading a 30.8 million pound sterling ($40.9 million) series B round that positions Epsilogen to try to create “a brand new category of pharmaceutical within within cancer.”
London-based Epsilogen’s primary focus is an immunoglobulin E (IgE) antibody that targets the folate receptor alpha antigen. While researchers discovered IgE antibodies in 1966, and biologics pioneers considered them at the birth of the biotech industry, Epsilogen claims its candidate is the world’s first IgE antibody to enter the clinic.
Epsilogen CEO Tim Wilson, who coined the term “Cinderella antibody,” framed the near-total dominance of IgG antibodies up to this point as a result of “folklore problems with IgE” that have “prevented people paying attention” to recent advances in understanding of the potential benefits of the antibodies.
“At the start, we did have a bit of an uphill struggle in persuading people that an IgE would be safe and readily manufacturable,” Wilson said. “If you talk to people in the pharma industry who go back to the 1980s, they'll tend to say ‘we thought about IgE way back when and we were worried about anaphylaxis and we were worried about manufacturing’. Well, we've answered those two questions.”
The anaphylaxis worry stems from the fact IgE antibodies drive the allergic immune response. In a trial of 24 solid tumor patients who were free from concomitant medications or comorbidities increasing risk of anaphylaxis, Epsilogen saw one case of the severe immune reaction. The patient was treated successfully for anaphylaxis with adrenaline.
Epsilogen emerged from the trial with a way to screen out patients who are at higher risk of anaphylaxis. The patient who had the severe immune reactions was the only one of the 24 subjects who was positive on the basophil activation test at baseline.
The worry about the manufacturability of IgE antibodies reflects the fact the molecules are bigger and more heavily glycosylated than IgG antibodies. While Epsilogen is still operating at fairly small scales, its initial manufacturing runs are encouraging, with several CDMOs producing more than 90 different IgEs at expression levels comparable with IgGs.
If, as Wilson believes, Epsilogen’s early clinical and manufacturing data clear the historical barriers to IgEs, that leaves one big outstanding question: Why use IgEs over tried-and-tested IgG antibodies?
The case for using IgE antibodies rests on data generated in recent years, notably by Sophia Karagiannis’ laboratory at King's College London. Karagiannis, Ph.D., a scientific founder of Epsilogen, and other researchers have shed light on the role of IgE antibodies and their relevance for oncology. IgE antibodies stimulate myeloid lineage cell responses, in particular macrophages and monocytes, to remove parasites. Applied to cancer, that mechanism could turn the immune system against solid tumors.
“We are changing the tropism of an immunoreactive warrior class of cells. When you stick something on their cell membrane that says, ‘I will bind to folate receptor alpha,’ they will seek it out. That's what they're there to do. It doesn't matter whether it’s a schistosome or a breast cancer cell,” Wilson said.
Novartis Venture Fund sees promise in the idea, teaming up with new investors 3B Future Health Fund, British Patient Capital, Schroders Capital and Caribou Property along with existing backers Epidarex Capital and ALSA Ventures to pump 30.8 million pounds into Epsilogen. The money will fund a phase 1b clinical trial that will test MOv18 IgE in platinum-resistant ovarian cancer patients, a population in whom standard of care has an objective response rate of 10% to 12%.
“If we can beat that number significantly, we're in good shape,” Wilson said. “We hope to establish clinical proof of concept. If we get that, I expect the industry will realize that we have a brand new category of pharmaceutical within cancer.”
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